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This study aims to evaluate and compare patient satisfaction and prosthetic complications between two types of prostheses: milled bar and screw-retained prostheses, used for supporting maxillary subperiosteal implants. Patients requiring maxillary rehabilitation using subperiosteal implants will be randomly assigned to receive either a milled bar-retained prosthesis or a screw-retained prosthesis. Patient satisfaction and any prosthetic complications will be clinical assessed and followed up over a one-year period to determine which prosthetic design offers better clinical outcomes and patient experience.
Patients enrolled in this randomized clinical trial will undergo surgical placement of maxillary subperiosteal implants. Following the healing period, patients will be allocated into two treatment groups. Group 1 will receive a milled bar-retained prosthesis, while Group 2 will receive a screw-retained prosthesis. Baseline data and clinical parameters will be recorded. Throughout the one-year follow-up period, patient satisfaction will be evaluated using standardized questionnaires or visual analog scales (VAS). Additionally, prosthetic complications-such as screw loosening, fracture, or bar-related issues-will be closely monitored and documented at regular follow-up intervals to comprehensively compare the two restorative modalities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Milled Bar-Retained Prosthesis | Experimental | Patients in this group will receive a milled bar-retained prosthesis supported by maxillary subperiosteal implants. Patient satisfaction and prosthetic complications will be evaluated over a one-year follow-up period. |
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| Group 2: Screw-Retained Prosthesis | Experimental | Patients in this group will receive a screw-retained prosthesis supported by maxillary subperiosteal implants. Patient satisfaction and prosthetic complications will be evaluated over a one-year follow-up period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maxillary subperiosteal implant with milled bar-retained prosthesis | Device | Surgical placement of a custom-milled, patient-specific CAD/CAM maxillary subperiosteal implant. Following the healing and provisional phase, a definitive milled bar-retained overdenture prosthesis will be fabricated and attached to support full-arch rehabilitation. |
| Measure | Description | Time Frame |
|---|---|---|
| Prosthetic Complications | Aesthetic -mechanical -functional and biological categories | Baseline (immediately following prosthesis placement) and after one year |
| Patient satisfaction | Patient satisfaction will be evaluated using a Visual Analog Scale (VAS), where scores range from 0 to 10. A score of 0 represents complete dissatisfaction, while a score of 10 represents complete satisfaction with the prosthesis | Baseline (immediately following prosthesis placement) and after one year |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry of Mansoura University | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
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Participants will be randomly allocated into two parallel groups to receive either a milled bar-retained prosthesis or a screw-retained prosthesis
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| Maxillary subperiosteal implant with screw-retained prosthesis | Device | Surgical placement of a custom-milled, patient-specific CAD/CAM maxillary subperiosteal implant. Following the healing and provisional phase, a definitive screw-retained prosthesis will be fabricated and fixed to support full-arch rehabilitation. |
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| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
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